Changeflow GovPing Drug Safety Kisqali Tablets: Updated Storage Conditions and...
Routine Notice Amended Final

Kisqali Tablets: Updated Storage Conditions and Shelf Life

Favicon for www.bfarm.de BfArM Drug Safety Communications
Published February 2nd, 2026
Detected March 13th, 2026
Email

Summary

Novartis Pharma GmbH has updated the storage conditions and shelf life for Kisqali 200 mg film-coated tablets. The medicine no longer requires refrigeration and now has an authorized shelf life of 2 years. This information letter was issued by the BfArM.

What changed

Novartis Pharma GmbH, in an information letter issued by the BfArM on February 2, 2026, has announced changes to the storage conditions and shelf life for Kisqali 200 mg film-coated tablets (active substance: ribociclib). The key changes include the removal of the requirement for refrigerated storage and an extension of the authorized shelf life to 2 years. The medicine should continue to be stored in its original packaging to protect it from moisture.

Healthcare providers and pharmaceutical distributors should update their inventory management and dispensing protocols to reflect these new storage requirements and the extended shelf life. While no specific compliance deadline is mentioned, it is advisable to implement these changes promptly to ensure proper product handling and patient safety. This update primarily affects the handling and storage practices for the specified medication.

What to do next

  1. Update inventory and dispensing protocols for Kisqali 200 mg to reflect new storage requirements (no refrigeration) and 2-year shelf life.
  2. Ensure Kisqali 200 mg is stored in original packaging to protect from moisture.

Source document (simplified)

Information letter on Kisqali 200 mg film-coated tablets: Change in storage conditions and shelf life

2026.02.02

Active substance: ribociclib

Novartis Pharma GmbH informs about changes in storage conditions and shelf life for Kisqali 200 mg. The medicine should be stored in the original packaging to protect the contents from moisture. Storage in the pharmacy in the refrigerator is no longer necessary. The authorised shelf life of Kisqali is now 2 years.

Download DHPC/Information letter, DownloadVeroeffentlichtAmEN

2026.02.02

PDF, 777KB, File does not meet accessibility standards

Classification

Agency
Various
Published
February 2nd, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Drug manufacturers Healthcare providers
Geographic scope
National (Germany)

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Pharmaceuticals Product Safety

Get Drug Safety alerts

Weekly digest. AI-summarized, no noise.

Free. Unsubscribe anytime.

Get alerts for this source

We'll email you when BfArM Drug Safety Communications publishes new changes.

Free. Unsubscribe anytime.